The Invacare Adventure Series of Scooters are motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to persons limited to a seated position. The scooters are basic conventional rear wheel drive, rigid frame vehicles that are battery powered. Various options and accessories are available depending upon user needs and preferences. They consist primarily of a welded steel frame, transaxle motor drive system, braking system, electronic motor controller and an adjustable seat. They also include a tiller handle for steering and a throttle control to engage and disengage the scooter motion in both the forward and reverse directions. The scooters can also be disassembled for ease of transport, are powered by two (2) 12 volt DC batteries, and utilize an on-board charger. The scooters have a status indicator located on the face of the control panel that provides diagnostic information. The status LED will flash a certain number of times, separated by a pause when a fault is detected in the controller or in the wiring. This feature is for diagnostic information only and does not control the operation of the scooter. The Adventure SX-3 is a compact version of the scooter with a 250 lb. weight capacity while the Adventure LX-3 scooter is a mid-size version of the scooter with a 350 lb. weight capacity.

AI/ML Overview

This document describes a 510(k) premarket notification for the Invacare Adventure Motorized Scooters. This type of submission relies on demonstrating substantial equivalence to a predicate device already on the market, rather than conducting new clinical trials or extensive performance studies for regulatory approval. As such, the structure of the data provided is different from what would be expected for a novel AI/medical imaging device.

Here's an analysis based on the provided text, addressing your questions where applicable, and noting when the information is not present due to the nature of a 510(k) submission for a non-AI device:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device (motorized scooter), performance is typically assessed against established industry standards for safety and functionality, rather than specific diagnostic accuracy metrics.

Acceptance Criteria (Applicable Standards)	Reported Device Performance
ANSI/RESNA WC/14 (1991)	Meets Applicable Requirements: "The Invacare Models Lynx and Panther scooters meet the applicable requirements specified in the Rehabilitation Engineering Society of North America (RESNA) Standard ANSI/RESNA WC/14 (1991)."
ISO 7176: 1993 (E)	Meets Applicable Requirements: "...and ISO Standard ISO 7176: 1993 (E) 'ISO Standard, Wheelchairs – Requirements and Test Methods for the Power and Control Systems of Electric Wheelchairs.'"
California 116 and 117 Specifications for Fire Retardancy	Meets Specifications: "The upholstery materials meet California 116 and 117 specifications for fire retardancy."
Substantial Equivalence to Predicate Device (Lynx scooters K010135)	Claimed Substantially Equivalent: "While there are minor differences in performance specifications of the scooters, these differences do not alter the intended function and use of the device, nor do they raise any new questions pertaining to safety or effectiveness. Therefore, Invacare believes that the Adventure series of scooters are substantially equivalent to legally marketed devices currently in commercial distribution."

2. Sample Size Used for the Test Set and Data Provenance

This information is not applicable in the context of this 510(k) submission for a motorized scooter. There isn't a "test set" of patient data in the way one would analyze for an AI diagnostic device. The performance data refers to the scooter itself meeting engineering and safety standards, likely through bench testing, materials testing, and mechanical evaluations of the physical product.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This information is not applicable. Ground truth, in the sense of expert consensus on diagnostic findings, is not relevant for the regulatory approval of a motorized scooter. The "truth" here is whether the physical product adheres to engineering standards.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among human readers or experts when establishing ground truth for diagnostic studies. This is not performed for mechanical device evaluation.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improving with AI vs. Without AI Assistance

This information is not applicable. This submission is for a physical medical device (motorized scooter), not an AI diagnostic tool. Therefore, no MRMC study or analysis of human reader improvement with AI assistance was conducted or would be relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable. This device is a physical product, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is adherence to established, published engineering and safety standards:

ANSI/RESNA WC/14 (1991) for wheelchairs.
ISO 7176: 1993 (E) for power and control systems of electric wheelchairs.
California 116 and 117 specifications for upholstery fire retardancy.

The device itself (scooter) is the object of evaluation against these standards, through physical testing, material analysis, and design verification.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" in the context of a physical medical device submission like this one. Training sets are used for machine learning algorithms.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable. As there is no training set for an AI algorithm, there is no ground truth established for it.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" in this context is a series of engineering evaluations, material tests, and design reviews that demonstrate the Invacare Adventure Scooters (and their components) meet the requirements of specific, recognized industry standards: ANSI/RESNA WC/14 (1991), ISO 7176: 1993 (E), and California 116 and 117. The primary method of demonstrating regulatory compliance under a 510(k) is to show substantial equivalence to existing legally marketed predicate devices (Invacare Lynx SX-3, Lynx LX-3, and Lynx LX-3P06 scooters, K010135). The submission states that "minor differences in performance specifications... do not alter the intended function and use of the device, nor do they raise any new questions pertaining to safety or effectiveness," which is the core argument for substantial equivalence. The FDA, by granting clearance, concurred with this assessment.

Summary

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MAR 2 0 2003

K030814

510(k) SUMMARY INVACARE CORPORATION'S 510(k) PREMARKET NOTIFICATION ADVENTURE MOTORIZED SCOOTERS

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared.

Invacare Corporation One Invacare Way Elyria, Ohio 44036 Phone: (440) 329-6000 Facsimile: (440) 365-4558

Contact Person: Rae Ann Farrow Manager, Regulatory Compliance

Date Prepared: March 13, 2003

Name of Device and Name/Address of Sponsor:

Name of Device: Invacare Adventure Series Scooters

Invacare Corporation One Invacare Way Elyria, Ohio 44036 Phone: (440) 329-6000 Facsimile: (440) 366-9724

Common or Usual Name

Scooter

Classification Name

Motorized Three Wheel Vehicle

Predicate Devices

The Adventure Scooters are substantially equivalent to the Lynx scooters (K010135, 2/16/2001).

Intended Use

The intended use of the Adventure scooters is to provide mobility to persons limited to a seated position.

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Technological Characteristics and Substantial Equivalence

Device Description

The Invacare Adventure Series of Scooters are motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to persons limited to a seated position.

The scooters are basic conventional rear wheel drive, rigid frame vehicles that are battery powered. Various options and accessories are available depending upon user needs and preferences. They consist primarily of a welded steel frame, transaxle motor drive system, braking system, electronic motor controller and an adjustable seat. They also include a tiller handle for steering and a throttle control to engage and disengage the scooter motion in both the forward and reverse The scooters can also be disassembled for ease of transport, are directions. powered by two (2) 12 volt DC batteries, and utilize an on-board charger.

The scooters have a status indicator located on the face of the control panel that provides diagnostic information. The status LED will flash a certain number of times, separated by a pause when a fault is detected in the controller or in the wiring. This feature is for diagnostic information only and does not control the operation of the scooter.

The Adventure SX-3 is a compact version of the scooter with a 250 lb. weight capacity while the Adventure LX-3 scooter is a mid-size version of the scooter with a 350 lb. weight capacity.

Substantial Equivalence

Products, which are substantially equivalent to the Invacare Adventure scooters, include the Invacare Lynx SX-3, Lynx LX-3, and Lynx LX-3P06 scooters, which were granted clearance by FDA on February 16, 2001 on 510(k) accession number K010135. Each of these products are motorized, 3-wheel scooters with the same intended function and use of providing mobility to persons limited to a seated position.

While there are minor differences in performance specifications of the scooters, these differences do not alter the intended function and use of the device, nor do they raise any new questions pertaining to safety or effectiveness. Therefore, Invacare believes that the Adventure series of scooters are substantially equivalent to legally marketed devices currently in commercial distribution.

Performance Data

The Invacare Models Lynx and Panther scooters meet the applicable requirements specified in the Rehabilitation Engineering Society of North America (RESNA) Standard ANSI/RESNA WC/14 (1991) and ISO Standard ISO 7176: 1993 (E) "ISO Standard, Wheelchairs - Requirements and Test Methods for the Power and Control Systems of Electric Wheelchairs. The upholstery materials meet California 116 and 117 specifications for fire retardancy.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle.

MAR 2 0 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Rae Ann Farrow Manager, Regulatory Compliance Invacare Corporation One Invacare Way P.O. Box 4028 Elyria, OH 44036-2125

Re: K030814

Trade/Device Name: Invacare Adventure Series Scooters Regulation Number: 890.38002 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: II Product Code: INI Dated: March 13, 2003 Received: March 14, 2003

Dear Ms. Farrow:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

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Page 2 - Ms. Rae Ann Farrow

forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Mark N Millman

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): TBD

Device Name: Invacare Adventure Series Scooters

Indications For Use: To provide mobility to persons limited to a seated position.

Mark N Williamson

Division Signn. Restorative Division of Ge: and Neurologica. Devices

14 " 10(k) Number _

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use √

(Optional Format 1-2-96)

Regulation Number and Section

§ 890.3800 Motorized three-wheeled vehicle.

(a)
Identification. A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.(b)
Classification. Class II (performance standards).